Skip to Main Content
Don't have an account? Create Account
Loading more posts

Learn about the recently proposed Medicare rules that will broaden the scope of cuts to hospitals in the 340B Drug Pricing Program and to off-campus hospital outpatient departments.

view more »

Congress is expected to consider legislation to combat the opioid epidemic, fund the Department of Health and Human Services, and enable federal response to pandemic threats.

view more »

The Centers for Medicare & Medicaid Services has released Outpatient Prospective Payment System and Physician Fee Schedule proposed rules for calendar year 2019 that would expand site-neutral payment policies and continue Medicare Part B drug payment cuts to 304B hospitals.

view more »

America’s Essential Hospitals and the other plaintiffs are coordinating next steps and plan to promptly refile the case in district court.

view more »

The American Hospital Association, the Association of American Medical Colleges, and America’s Essential Hospitals expressed disappointment that the courts once again failed to rule on merits of the 340B case and vowed to continue the fight to reverse these unwarranted cuts.

view more »

Hospitals will have until Sept. 12 to complete the recertification process through the Office of Pharmacy Affairs Information System.

view more »

A Government Accountability Office witness and several 340B Drug Pricing Program stakeholders testified last week at a House committee hearing; another House committee marked up several consumer-driven health care bills.

view more »

The July 11 hearing will focus on contract pharmacies and a slate of 15 bills and discussion drafts related to the program; two essential hospital leaders will testify.

view more »

A new bill by Rep. Chris Collins (R-NY) would impose a user fee for hospitals participating in the 340B Drug Pricing Program; a House subcommittee marked up hospital preparedness and graduate medical education bills.

view more »

The House aims to complete voting by the July Fourth recess, but Senate work on opioid legislation likely will continue into August amid a shortened recess.

view more »

This is the latest of several delays of a rule that provides guidance on the calculation of ceiling prices and imposes civil monetary penalties on manufacturers who knowingly exceed them.

view more »

The dashboards, which show spending on drugs purchased in Medicaid and Medicare Parts B and D, for the first time include data on year-over-year price increases for individual drugs.

view more »

Senate Democrats sharply questioned the repeated delays of a final rule on drug ceiling prices and manufacturer civil monetary penalties; The House continues to focus on passing an opioid package.

view more »

The association urged the Health Resources and Services Administration to immediately implement a final rule establishing the calculation of ceiling prices and imposing manufacturer civil monetary penalties.

view more »

House leadership remains focused on passing a bipartisan opioid-related legislative package by Memorial Day, but recently indicated a June vote might be more likely.

view more »

The plan cites and builds on proposed changes to the 340B Drug Pricing Program in the president’s fiscal year 2019 budget, as well as damaging cuts implemented through the calendar year 2018 Outpatient Prospective Payment System final rule.

view more »

The proposal would delay by an additional year implementation of a final rule on ceiling prices and manufacturer civil monetary penalties in the 340B Drug Pricing Program.

view more »

Four House hearings this week examine the opioid crisis, as lawmakers work to craft bipartisan legislation; A Senate hearing focuses on oversight reports on the 340B Drug Pricing Program.

view more »

The decision to delay rules to safeguard patients and hospitals from drug company overcharges is unacceptable and undermines the 340B Drug Pricing Program.

view more »

On May 4, America’s Essential Hospitals and fellow plaintiffs will make oral arguments in a legal battle to reverse damaging Medicare cuts to hospitals in the 340B Drug Pricing Program; The public can watch via livestream.

view more »

The Centers for Medicare & Medicaid Services offers details on how Medicare Advantage plans might be affected by reimbursement reductions in the calendar year 2018 Outpatient Prospective Payment System final rule.

view more »

Even with its long record of success, the 340B program still faces undue scrutiny, distorted and misleading claims, and demands for onerous new reporting.

view more »

The budget plan for fiscal years 2018 and 2019 proposes changes to the distribution of 340B Drug Pricing Program savings and increased funding to fight the opioid crisis.

view more »

This badly misleading report makes no attempt to focus on or isolate the 340B drug payment policy. Rather, it masks the policy's damaging impact by conflating it with other unrelated policy changes.

view more »

America’s Essential Hospitals continues to fight to protect the 340B Drug Pricing Program, a crucial source of support for essential hospitals. Participants heard an overview of our recent advocacy activities and an update on our next steps.

view more »

Congress returns from recess to focus on long-term solutions after passing a short-term bill to fund the government through Jan. 19; lawmakers push for delay of 340B Drug Pricing Program cuts.

view more »

District court judge finds that the lawsuit was premature, but he does not rule on the merits of the claim by America's Essential Hospitals, the American Hospital Association, and the Association of American Medical Colleges.

view more »

While Congress grapples with competing priorities, legislative efforts to stop cuts to Medicare payments for the 340B Drug Pricing Program continue. America's Essential Hospitals urges all association members to contact their delegations today.

view more »

The new document details the use of two Medicare outpatient, claims-based modifiers hospitals will be required to report, starting Jan. 1, for drugs purchased through the 340B Drug Pricing Program.

view more »

America's Essential Hospitals urges all association members to call their House delegations today and urge them to cosponsor H.R. 4392, a bill that would halt enforcement of a damaging new Medicare policy that cuts Part B payments for 340B drugs by 27 percent.

view more »

Hospitals that contract with or are owned by state or local government must now identify a government official to attest to the hospital's classification.

view more »

America's Essential Hospitals urges all association members to contact their House delegations today and ask them to cosponsor H.R. 4392, a bill that would place a permanent moratorium on a new Centers for Medicare & Medicaid Services cut to 340B hospitals.

view more »

America's Essential Hospitals thanks Reps. David McKinley (R-WV) and Mike Thompson (D-CA) for legislation that would place a permanent moratorium on the Centers for Medicare & Medicaid Services policy to cut $1.6 billion in Medicare Part B drug reimbursement from 340B hospitals.

view more »

The lawsuit argues that the 340B provisions of the Centers for Medicare & Medicaid Services’ outpatient prospective payment system rule violate the Social Security Act and should be set aside under the Administrative Procedure Act as unlawful and in excess of the HHS Secretary’s statutory authority.

view more »

America’s Essential Hospitals is closely reviewing the final rules and pursuing strategies to protect our members from these devastating cuts. Key aspects of the recently released final rules are summarized in this Action Update.

view more »

Dive into the policy details of the CMS rule that cuts 340B program savings, and hear how America’s Essential Hospitals plans to respond.

view more »

Due to technical difficulties, the new 340B recertification period will run through Dec. 6; hospitals that already started the process must restart.

view more »

The rule cuts 340B Drug Pricing Program payments by $1.6 billion and requires hospitals to use modifiers to identify 340B drugs in Medicare claims.

view more »

The final rule's cuts to Medicare Part B drug payments to 340B hospitals jeopardizes health care access for millions of low-income individuals and families nationwide and weakens the ability of essential hospitals to provide vital services to communities.

view more »

Hospitals will have until Nov. 21 to complete the recertification process through the new Office of Pharmacy Affairs Information System.

view more »

The harmful payment reduction was included in the 2018 Outpatient Prospective Payment System proposed rule, expected to be finalized this fall.

view more »

The most recent delay to July 2018 comes after the Health Resources and Services Administration issued a proposed rule seeking feedback from stakeholders.

view more »

Providers can register a new entity or contract pharmacy through the 340B Office of Pharmacy Affairs Information System through Oct. 16.

view more »

The component enables manufacturers and covered entities to register for the 340B Drug Pricing Program, participate in annual recertification, and communicate with the Office of Pharmacy Affairs on pending tasks.

view more »

A push is underway on Capitol Hill to delay Medicaid disproportionate share hospital cuts and withdraw proposed 340B policy. Please urge your member of Congress to sign both letters.

view more »

Unless another delay is secured, Medicaid disproportionate share hospital payments will be cut by $2 billion beginning in fiscal year 2018, escalating to $8 billion by 2024.

view more »

The Sept. 13 webinar for covered entities will focus on the registration component of the new Office of Pharmacy Affairs Information System.

view more »

By cutting reimbursement rates for Part B drugs to 340B hospitals, the Centers for Medicare & Medicaid Services would harm essential hospitals, which care for the nation’s poorest, most complex, and costliest patients.

view more »

The Health Resources and Services Administration is seeking comments on whether to further delay implementation of a final rule on ceiling prices and civil monetary penalties in the 340B Drug Pricing Program by nine months.

view more »

The system will be unavailable from Aug. 15 until mid-September; hospitals are urged to verify contact information for authorizing officials and primary contacts in the system before Aug. 14.

view more »

The delay allows for implementation of a new online tool that will allow providers to register and recertify 340B sites and contract pharmacies.

view more »

The committee’s intentions remain unclear; we recommend essential hospitals prepare to publicly describe what auditors found and corrective actions taken.

view more »

The final rule on drug ceiling prices and manufacturer civil monetary penalties under the 340B Drug Pricing Program now will go into effect on Oct. 1.

view more »

HRSA has delayed until March 21 the effective date of a final rule on drug ceiling prices and manufacturer civil monetary penalties in the 340B program.

view more »

The regulation makes "penny pricing" final and sets fines of up to $5,000 per instance of a manufacturer overcharging providers for covered medications in the 340B Drug Pricing Program.

view more »

In this webinar we looked back at the 2016 advocacy landscape, discussed the progress we have made on key issues affecting essential hospitals, reviewed our interaction with the Trump transition team, and looked forward to 2017. Webinar Recording

view more »

Congress passed a bill to fund the government through Dec. 9. Meanwhile, 179 House members sent a letter urging CMS to stop mandatory payment and service delivery demonstrations.

view more »

Hospitals must complete recertification of their compliance with all requirements of the 340B program. Failure to do so results in removal from the program.

view more »

HRSA is proposing that a decision-making body within the Department of Health and Human Services be responsible for reviewing claims and resolving deputes.

view more »

The event, from 1 - 2 pm ET, will include important information on the annual recertification process and best practices.

view more »

Senate appropriators pass HHS spending bill that includes 340B Drug Pricing Program user fee and instructions to HRSA to consider stakeholder input in final mega-guidance.

view more »

The decision follows the pharmaceutical company's recent recalculation of 340B ceiling prices for 25 products for the third quarter of 2012 through the second quarter of 2013.

view more »

In new Modern Healthcare commentary, America's Essential Hospitals president and CEO says proposed guidance conflicts with HHS goals for readmissions, access, and care coordination.

view more »

A 2015 budget law that creates site-neutral payment for off-campus hospital outpatient departments does not directly affect 340B Drug Pricing Program eligibility, but changes to how hospitals report Medicare costs does raise concerns.

view more »

Proposed regulations would dramatically narrow access to 340B, harming vulnerable patients and putting entire communities at risk of losing vital services.

view more »

Final rule and implementation as described in the guidance could significantly reduce Medicaid payments for 340B-covered outpatient drugs in some states.

view more »

Webcasts, co-hosted by HRSA OPA and pharmacist association, will focus on helping covered entities identify steps needed to develop and maintain comprehensive 340B policies and procedures in an auditable manner.

view more »

House, Senate panels to examine rising cost of drugs, lack of transparency in the drug price negotiation process, and barriers to generic drug applications.

view more »

America's Essential Hospitals and two members systems host congressional staff for round-table discussions about how proposed 340B Drug Pricing Program guidance threatens vulnerable patients and essential hospitals.

view more »

Covered entities are no longer required to post a public letter to the HRSA website if 340B audit findings result in potential repayment. Instead, HRSA will publish notices with covered entity contact information.

view more »

Agency seeks comment on its proposal to collect information on the burden associated with guidelines for manufacturer audits of covered entities; comments are due to HRSA by Feb. 22.

view more »

Member leaders attend more than 100 meetings with lawmakers and congressional staff as part of fall Policy Assembly. Event also included insights from policymakers and a Capitol Hill reception honoring 2015 Gage Award recipients.

view more »

In comments to HRSA, association touches on restrictive patient definition, outpatient facility eligibility, and limits on qualifying drugs

view more »

U.S. District Court says 2014 HRSA interpretive rule is contrary to plain language of ACA provision that excludes certain hospitals from 340B discounts on orphan drugs.

view more »

Webinars help identify roles, responsibilities, and other 340B risk management elements, OPA and APhA also accepting leading practice site applications

view more »

Zydus Pharmaceuticals Inc., charged incorrect rates on 340B drugs between January 2012 and December 2014, refunds will be distributed via Apexus

view more »

Heritage Pharmaceuticals Inc., charged incorrect rates on 340B drugs between April 18, 2008 and Dec. 31, 2014, refunds are available

view more »

Proposed changes could significantly narrow the scope of patients for whom 340B pricing may be utilized and reduce potential savings from program

view more »

Omnibus guidance proposes an expanded list of six requirements for an individual to be considered a patient of a 340B covered entity.

view more »

Participants learned about HRSA's guidance on the 340B Drug Pricing Program and how it will affect their hospital.

view more »

Failure to recertify will result in removal from program, hospitals should have already received information from federal government needed to complete process.

view more »

Report suggests financial incentive for hospitals to prescribe 340B drugs, a claim America's Essential Hospitals calls unfounded and troubling.

view more »

Hospitals and covered entities currently enrolled in the 340B Drug Pricing Program are invited to a July 8 webinar to discuss the annual recertification process. The meeting will be hosted by the Office of Pharmacy Affairs (OPA), which is part of the Health Resources and Services Administration (HRSA). Hospitals are required to annually recertify that

view more »

Proposed rule also calls for increased transparency in ceiling price calculation, separate guidance to replace mega reg

view more »

Parts of the Cures package will now likely go to other House committees for review

view more »

We look forward to working with lawmakers to strengthen the 340B program in the future

view more »

It remains unclear what 340B Drug Pricing Program provisions could be included in the legislation

view more »

Energy and Commerce will vote on 21st Century Cures Wednesday; a 340B amendment may be included.

view more »

The association is pleased the Committee on Energy and Commerce is working collaboratively with stakeholders.

view more »

Letter emphasizes value of program to vulnerable patients and hospitals, and risk of harming care by limiting program access

view more »

For now, lawmakers focused on information gathering, better oversight, clarity, and accountability

view more »

Contact your lawmakers on the House Energy and Commerce and Senate Health, Education, Labor, and Pensions committees to underscore the critical need for the 340B program.

view more »

Learn more about association and member efforts to defend the 340B Drug Pricing Program

view more »

Commentary argues to keep program savings with essential hospitals to benefit low-income patients and entire communities

view more »

HRSA had submitted a 340B proposed rule to OMB, but a subsequent court ruling questioned the agency's authority to issue a rule

view more »

Latest critique of 340B disappoints with fiction and unsupported assertions, rather than the plain facts of this important program

view more »

Webinar will cover recent changes to audit process; OPA also working to standardize process for self-disclosing a 340B requirement breach

view more »

The lawsuit would challenge OPA's interpretative rule implementing the orphan drug provision for new 340B covered entities under the ACA

view more »

OPA notify hospitals via email of the need to recertify for eligibility for the 340B program.

view more »

These members of Congress went on record supporting the 340B Drug Pricing Program and the patients it benefits.

view more »

New interpretive rule will address the 340B orphan drug exclusion.

view more »

In particular, OPA has changed the process for correcting or addressing findings on which covered entities and auditors disagree.

view more »

HRSA stands by its interpretation of the 340B orphan drug rule

view more »

The regulations provide guidance for the AIDS Drug Assistance Program and the National Hemophilia Program

view more »

The U.S. District Court for the District of Columbia vacated HHS' final rule on orphan drug pricing and granted an injunction that prevents HHS from implementing the rule.

view more »

The webinar will be held June 9 at 2 pm ET.

view more »

Stakeholders will discuss several 340B policy matters including the forthcoming mega-reg.

view more »

Discussions included hospital eligibility in 340B, the definition of a patient at 340B-eligible hospitals, and contract pharmacies

view more »

Senate Democrats sent a letter to OMB and HRSA supporting the 340B program, appropriations committees begin their markup processes

view more »

Lawmakers in both the House and Senate introduced a consensus bill to repeal the Medicare physician payment system, which is partially based on the sustainable growth rate

view more »

The OIG gathered information from a sample of covered entities to learn about their contract pharmacy arrangements.

view more »

Association, two other national organizations file amicus brief in support of HRSA interpretation of law

view more »

Analysis finds program is likely to grow in states expanding their Medicaid program

view more »

Failure to complete recertification could result in dismissal from program

view more »

All 340B authorizing officials expected to receive access to complete process by email

view more »

Separate physical inventories not required for compliance with group purchasing organization prohibition guidance

view more »

Senator's letter requests specific information about 340B covered entities

view more »

Certain providers may receive drug discounts for uses outside indication associated with orphan designation

view more »

On law's 20th anniversary, members of Congress say law helps reduce drug costs for hundreds of hospital

view more »

President and CEO Bruce Siegel focused on program's benefits to patients and the hospitals on which they depend

view more »

Hospitals urged to review language on certification of compliance with group purchasing organization guidance

view more »

Deadline extended after significant pressure from America's Essential Hospitals and association members

view more »